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NCT00099164 · ClinicalTrials.gov registry record · Phase 3

Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS)

A Phase 3 study, sponsored by The George Washington University Biostatistics Center.

Completed
Registry status
Phase 3
Development phase
795
Enrollment target

NCT00099164: Completed Phase 3 study, sponsored by The George Washington University Biostatistics Center.

NCT00099164 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 795 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00099164, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.

COMPLETED
Registry status
Phase 3
Development phase
795 participants
Enrollment target

Study Summary

Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially reduces the rate of preterm birth in women at high risk for preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among progesterone-treated women with a singleton pregnancy when compared with women receiving placebo. The current trial compares weekly treatment by injection of progesterone with placebo in women pregnant with twins or triplets.

Interventions

  • DRUG 17 alpha-hydroxyprogesterone caproate (17P)

Trial Details

FieldValue
Enrollment Target 795 participants
Start Date 2004-04
Est. Completion 2007-09
Phase Phase 3

What the finished NCT00099164 record still lists

NCT00099164 is an interventional study that assigns participants to a tested intervention. The registered 795 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which 17 alpha-hydroxyprogesterone caproate (17P) is the first listed.

NCT00099164 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00099164 about?

NCT00099164 is a clinical study titled "Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS)". Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially...

What is the current status of trial NCT00099164?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 795 participants. The study started on 2004-04. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00099164?

The interventions under investigation include: 17 alpha-hydroxyprogesterone caproate (17P) (DRUG).

Who is sponsoring clinical trial NCT00099164?

This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00099164's enrollment target sits among peer trials

795 428th of 2000 higher than 1,572 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00099164, the US trial registry maintained by the National Library of Medicine. NCT00099164 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.